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Clinical Trial of Intravenous Infusion of Fucosylated Bone Marrow Mesenchyme Cells in Patients With Osteoporosis (CSM/OP/2011)

Primary Purpose

Osteoporosis, Spinal Fractures

Status
Completed
Phase
Phase 1
Locations
Spain
Study Type
Interventional
Intervention
Fucosylated MSC for Osteoporosis
Sponsored by
Red de Terapia Celular
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoporosis

Eligibility Criteria

50 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with established osteoporosis according to standard clinical criteria.
  • Patients who give their written informed consent to participate in the study consent.
  • Meet all the inclusion criteria

Exclusion Criteria:

  • Patients with concomitant systemic disease in the opinion of the investigator.
  • Patients with rheumatoid arthritis, ankylosing spondylitis, chronic polyarticular arthritis.
  • Current patients with neoplasm or history of any malignancy in the last 10 years except basal carcinoma or epidermoid skin.
  • Patients with genetic disorders that are associated with secondary osteoporosis: Hemochromatosis, hypophosphatasia, osteogenesis imperfecta, Ehlers-Danlos syndrome, Marfan syndrome, Riley Day, porphyria, storage diseases syndrome.
  • Patients receiving immunosuppressive chemotherapy or that could interfere with the process of cell proliferation.
  • Transplant patients: bone marrow, kidney, liver, heart, lung.
  • Patients with clinical criteria and anesthetics that contraindicate well sedation or bone marrow extraction.
  • Patients participating in a clinical trial in the last 6 months.
  • Patients with positive serology for hepatitis B, hepatitis C or HIV.
  • Patients with inability to understand informed consent.
  • Patients who are pregnant or breast-feeding actively.
  • Patients physically fertile, defined as all women physiologically capable of becoming pregnant, UNLESS they are using reliable methods of contraception.

Sites / Locations

  • Hospital Clínico Virgen de la Arrixaca

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Fucosylated MSC for Osteoporosis

Arm Description

Autologous Bone Marrow fucosylated mesenchymal stem cells will be infused intravenously on Day 0. The first four patients enrolled will receive a single dose of 2 million cells/Kg and the last six patients enrolled, will receive a single dose of 5 million cells/kg.

Outcomes

Primary Outcome Measures

Rate of serious and non-serious adverse events related to the procedure.
During time frame the following items will be considered: Adverse effects related to the infusion moment. Occurrence of infectious complications after infusion of mesenchymal stem cells, because of the immunosuppressive effect of these cells. Appearance of procedure-related neoplasias.

Secondary Outcome Measures

Number of new fractures
Pain, measured by Visual Analog Scale
To measure pain, visual analogue scale (VAS) was used where 0 is no pain and 10 the worst pain imaginable.
Functionality, measured by Oswestry Disability Questionnaire
To identify the functional repercussion of lumbar pain, Oswestry Disability Questionnaire for back pain or Oswestry Disability Index is used.
Quality of Life, measured by EuroQoL-5D test
To measure the quality of life EuroQoL-5D psychometric test is used.
Bone resorption, measured by biochemical index
Aminoterminal telopeptide of type 1 collagen in the serum (serum NTX) (%) by ELISA technique.
Bone formation, measured by biochemical index
Osteocalcin in the serum by ELISA (BPG serum) (ng / mL) .
Bone formation, measured by biochemical index
Bone specific alkaline phosphatase in the serum by ELISA (serum FAO) (ug / L)
Bone formation, measured by biochemical index
Aminoterminal propeptide of procollagen type 1 in the serum by ELISA (serum P1NP) (ng / mL)
Bone metabolism, measured by biochemical index
Osteoprotegerin (OPG) (pmol / L) in the serum by ELISA.
Bone metabolism, measured by biochemical index
Ligand receptor activator of nuclear factor KB (RANKL) (pmol / L) in the serum by ELISA.
Bone Mineral Density , measured by dual energy x-ray absorptiometry (DXA)
Bone structure, measured by histomorphometric evaluation
Trabecular bone density measured by quantitative computed tomography of the radius

Full Information

First Posted
January 30, 2015
Last Updated
October 7, 2020
Sponsor
Red de Terapia Celular
Collaborators
Instituto Murciano de Investigación Biosanitaria Virgen de la Arrixaca, Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia, Hospital Universitario Virgen de la Arrixaca, Spanish National Health System, Public Health Service, Murcia, BIONAND, Universidad de Málaga, IBIMA, Ciber-bbn, Grupo de Tecnología Sanitaria CIBER-BBN, Inst. Biomecánica de Valencia
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1. Study Identification

Unique Protocol Identification Number
NCT02566655
Brief Title
Clinical Trial of Intravenous Infusion of Fucosylated Bone Marrow Mesenchyme Cells in Patients With Osteoporosis
Acronym
CSM/OP/2011
Official Title
Phase I Clinical Trial To Evaluate The Intravenous Infusion Of Autologous Fucosylated Bone Marrow Mesenchymal Cells Therapy In Patients With Established Osteoporosis and Low Impact Fractures
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
September 2015 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
May 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Red de Terapia Celular
Collaborators
Instituto Murciano de Investigación Biosanitaria Virgen de la Arrixaca, Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia, Hospital Universitario Virgen de la Arrixaca, Spanish National Health System, Public Health Service, Murcia, BIONAND, Universidad de Málaga, IBIMA, Ciber-bbn, Grupo de Tecnología Sanitaria CIBER-BBN, Inst. Biomecánica de Valencia

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to evaluate the safety of intravenous infusion of fucosylated autologous bone marrow cells as a new therapy in patients with established osteoporosis by a prospective, single-center, open, non-randomized and unblinded clinical trial.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis, Spinal Fractures

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Fucosylated MSC for Osteoporosis
Arm Type
Experimental
Arm Description
Autologous Bone Marrow fucosylated mesenchymal stem cells will be infused intravenously on Day 0. The first four patients enrolled will receive a single dose of 2 million cells/Kg and the last six patients enrolled, will receive a single dose of 5 million cells/kg.
Intervention Type
Biological
Intervention Name(s)
Fucosylated MSC for Osteoporosis
Intervention Description
Aproximately 30 days before the infusion of the investigational product, patient bone marrow will be obtained according to standard practice of the Haematology University Hospital Virgen de la Arrixaca (HCUVA). Mononuclear bone marrow cells will be separated and cultured in GMP conditions to purify and obtain mesenchymal cell established dose range. The infusion day BM-MSCs will be fucosylated and resuspended in saline to a concentration of 5 million cells per 1 mL. Then, the final product will be packaged in syringes for intravenous administration to patients through a peripheral venous access.
Primary Outcome Measure Information:
Title
Rate of serious and non-serious adverse events related to the procedure.
Description
During time frame the following items will be considered: Adverse effects related to the infusion moment. Occurrence of infectious complications after infusion of mesenchymal stem cells, because of the immunosuppressive effect of these cells. Appearance of procedure-related neoplasias.
Time Frame
24 months from baseline
Secondary Outcome Measure Information:
Title
Number of new fractures
Time Frame
24 months from baseline
Title
Pain, measured by Visual Analog Scale
Description
To measure pain, visual analogue scale (VAS) was used where 0 is no pain and 10 the worst pain imaginable.
Time Frame
24 months from baseline
Title
Functionality, measured by Oswestry Disability Questionnaire
Description
To identify the functional repercussion of lumbar pain, Oswestry Disability Questionnaire for back pain or Oswestry Disability Index is used.
Time Frame
24 months from baseline
Title
Quality of Life, measured by EuroQoL-5D test
Description
To measure the quality of life EuroQoL-5D psychometric test is used.
Time Frame
24 months from baseline
Title
Bone resorption, measured by biochemical index
Description
Aminoterminal telopeptide of type 1 collagen in the serum (serum NTX) (%) by ELISA technique.
Time Frame
24 months from baseline
Title
Bone formation, measured by biochemical index
Description
Osteocalcin in the serum by ELISA (BPG serum) (ng / mL) .
Time Frame
24 months from baseline
Title
Bone formation, measured by biochemical index
Description
Bone specific alkaline phosphatase in the serum by ELISA (serum FAO) (ug / L)
Time Frame
24 months from baseline
Title
Bone formation, measured by biochemical index
Description
Aminoterminal propeptide of procollagen type 1 in the serum by ELISA (serum P1NP) (ng / mL)
Time Frame
24 months from baseline
Title
Bone metabolism, measured by biochemical index
Description
Osteoprotegerin (OPG) (pmol / L) in the serum by ELISA.
Time Frame
24 months from baseline
Title
Bone metabolism, measured by biochemical index
Description
Ligand receptor activator of nuclear factor KB (RANKL) (pmol / L) in the serum by ELISA.
Time Frame
24 months from baseline
Title
Bone Mineral Density , measured by dual energy x-ray absorptiometry (DXA)
Time Frame
24 months from baseline
Title
Bone structure, measured by histomorphometric evaluation
Time Frame
baseline and 4 months from baseline
Title
Trabecular bone density measured by quantitative computed tomography of the radius
Time Frame
24 months from baseline

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with established osteoporosis according to standard clinical criteria. Patients who give their written informed consent to participate in the study consent. Meet all the inclusion criteria Exclusion Criteria: Patients with concomitant systemic disease in the opinion of the investigator. Patients with rheumatoid arthritis, ankylosing spondylitis, chronic polyarticular arthritis. Current patients with neoplasm or history of any malignancy in the last 10 years except basal carcinoma or epidermoid skin. Patients with genetic disorders that are associated with secondary osteoporosis: Hemochromatosis, hypophosphatasia, osteogenesis imperfecta, Ehlers-Danlos syndrome, Marfan syndrome, Riley Day, porphyria, storage diseases syndrome. Patients receiving immunosuppressive chemotherapy or that could interfere with the process of cell proliferation. Transplant patients: bone marrow, kidney, liver, heart, lung. Patients with clinical criteria and anesthetics that contraindicate well sedation or bone marrow extraction. Patients participating in a clinical trial in the last 6 months. Patients with positive serology for hepatitis B, hepatitis C or HIV. Patients with inability to understand informed consent. Patients who are pregnant or breast-feeding actively. Patients physically fertile, defined as all women physiologically capable of becoming pregnant, UNLESS they are using reliable methods of contraception.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luis F Linares Ferrando, MD
Organizational Affiliation
Hospital Universitario Virgen de la Arrixaca
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Clínico Virgen de la Arrixaca
City
El Palmar
State/Province
Murcia
ZIP/Postal Code
30120
Country
Spain

12. IPD Sharing Statement

Learn more about this trial

Clinical Trial of Intravenous Infusion of Fucosylated Bone Marrow Mesenchyme Cells in Patients With Osteoporosis

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